Orange Book product · Brand (NDA)
TIVICAY PD
DOLUTEGRAVIR SODIUM
At a glance
Jun 12, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 12, 2020
6 yr 1 mo ago
Today
Patent 8129385 expires
Listed drug substance patent expiration.
Oct 05, 2027
in 1 yr 4 mo
Patent 8129385*PED expires
Listed listed patent expiration.
Apr 05, 2028
in 1 yr 10 mo
Patent 9242986 expires
Listed drug substance patent expiration.
Dec 08, 2029
in 3 yr 6 mo
Patent 9242986*PED expires
Listed listed patent expiration.
Jun 08, 2030
in 4 yr
Pharmaceutical detail
Active ingredient
DOLUTEGRAVIR SODIUM
Strength
EQ 5MG BASE
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 213983
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8129385 | Oct 05, 2027 | in 1 yr 4 mo | SubstanceProduct |
| 8129385*PED | Apr 05, 2028 | in 1 yr 10 mo | |
| 9242986 | Dec 08, 2029 | in 3 yr 6 mo | SubstanceProduct |
| 9242986*PED | Jun 08, 2030 | in 4 yr |
